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-- WITH PHOTO -- TO BUSINESS, HEALTH, AND MEDICAL EDITORS:
'Best of the Best' SynCardia Certified Centers Earn Honors for Giving
End-Stage Heart Failure Patients a Second Chance at Life
TUCSON, Ariz., April 1, 2014 /PRNewswire/ -- Nine 'best of the best'
SynCardia Certified Centers were honored by SynCardia Systems, Inc.,
for their use of the SynCardia temporary Total Artificial Heart, the
world's first and only FDA, Health Canada and CE approved Total
Artificial Heart, and the Freedom@ portable driver that powers it.
Most SynCardia patients are considered the sickest of the sick. "Crash
and Burn" and "Progressive Decline" are used to describe these
INTERMACS 1 and 2 end-stage heart-failure patients who need
"definitive intervention" within days or hours to survive.
According to data published in the New England Journal of Medicine1
from the 10-year pivotal clinical study that led to FDA approval, 79%
of patients who received the Total Artificial Heart were bridged to
transplant of a donor heart. This is the highest bridge to transplant
rate for any approved heart device in the world.
Outstanding Outcomes
All patients who received SynCardia Heart implants in 2012 and 2013 at
these centers were either bridged to a donor heart transplant or alive
with SynCardia Heart support during those years. Many awaiting donor
hearts are at home supported by the Freedom portable driver.*
-- UCLA Medical Center, Los Angeles, CA
-- Sentara Heart Hospital, Norfolk, VA
-- A SynCardia Certified Center in Minnesota
Implant Leaders
For leadership in the use of the SynCardia Total Artificial Heart and
Freedom portable driver:
-- Cedars-Sinai Medical Center team, Los Angeles, implanted more
SynCardia Hearts in a single year-23 in 2013-than any other SynCardia
Certified Center.
-- Evangelisches Krankenhaus Duisburg-Nord team, Germany, conducted 13
SynCardia Heart implants in 2013, more than any center outside of the
United States.
Fast Start
-- Stanford University Medical Center, Palo Alto, CA, implanted five
SynCardia Hearts in 2013, its first year as a SynCardia Certified
Center.
-- University of Nebraska Medical Center, Omaha, implanted four
SynCardia Hearts last year when it became a SynCardia Certified
Center.
-- Gazientep University Hospital, Turkey, implanted four SynCardia
Hearts.
Emerging Leaders
-- Dr. H. Todd Massey and the University of Rochester Medical Center
were recognized as emerging leaders for their commitment in
strengthening their SynCardia Total Artificial Heart program and
efforts to assist other SynCardia Certified Centers do the same. Dr.
Massey is a surgical proctor for new centers doing their first
SynCardia implant.
More than 400 SynCardia Total Artificial Heart implants have been
performed since January 2011. The SynCardia Heart has provided almost
130,000 patient days of support in nearly 1,300 implants. The youngest
patient to receive a SynCardia Heart was 9 years old; the oldest was
76 years old.
At only 13.5 pounds, the Freedom portable driver provides patients
with almost unlimited mobility. It is pending FDA approval and is
approved by Health Canada and the CE Mark for Europe. A majority of
clinically stable patients are discharged with the Freedom driver to
recover at home and in their communities as they wait for donor
hearts.
Tops in Reliability
During 30 years of use, the valves in the SynCardia Total Artificial
Heart have never failed. The diaphragm, which is responsible for
pumping blood in and out of the ventricles, has a failure rate of less
than one half of 1% for nearly 1,300 implants (2,600+ diaphragms).
>> Read Ceder Sinai's Press Release: Cedars-Sinai Heart Institute Sets
New Standard for Most US Heart Transplants in a Year
*CAUTION - The Freedom portable driver is an investigational device,
limited by United States law to investigational use.
1 N Engl J Med 2004;351:859-67
About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held
manufacturer of the world's first and only FDA, Health Canada and CE
approved Total Artificial Heart. Originally used as a permanent
replacement heart, the SynCardia Total Artificial Heart is currently
approved as a bridge to transplant for people suffering from end stage
heart failure affecting both sides of the heart (biventricular
failure).
There have been nearly 1,300 implants of the Total Artificial Heart,
accounting for more than 350 patient years of life on the device.
Similar to a heart transplant, the SynCardia Total Artificial Heart
replaces both failing heart ventricles and the four heart valves. It
is the only device that eliminates the symptoms and source of end
stage biventricular failure. Unlike a donor heart, the Total
Artificial Heart is immediately available at 97 SynCardia Certified
Centers worldwide with 39 others in the process of certification.
The Total Artificial Heart provides immediate, safe blood flow of up
to 9.5 liters per minute through each ventricle. This high volume of
blood flow helps speed the recovery of vital organs, helping make the
patient a better transplant candidate.
For additional information, please visit: http://www.syncardia.com/
Like SynCardia on Facebook Follow SynCardia on Twitter -
@SynCardia Connect with SynCardia on LinkedIn
Photo - http://photos.prnewswire.com/prnh/20140401/LA94725
SOURCE SynCardia Systems, Inc.
-0- 04/01/2014
/CONTACT: Don Isaacs, Vice President of Communications, SynCardia Systems, Inc., Cell: (520) 955-0660, disaacs@syncardia.com
/Photo: http://photos.prnewswire.com/prnh/20140401/LA94725
PRN Photo Desk, photodesk@prnewswire.com
/Web Site: http://www.syncardia.com
CO: SynCardia Systems, Inc.
ST: Arizona
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SU: AWD
PRN
-- LA94725 --
0000 04/01/2014 12:55:00 EDT http://www.prnewswire.com
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